Program of Research for the Optimization of a Supervised Patient Pathway for Expectant According to Risk in Obstetrics

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Other: control; Behavioral: PROSPERO

• Registration Number: NCT02593292
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

This French multicentre open-label randomized trial will test the hypothesis that a coordinated health circuit based on obstetric risks, backed up by an electronic patient care reporting information system will optimize the continuum of pregnancy care monitoring. The electronic patient care reporting information system will be shared between patients, private practice physicians/midwifes, hospital physicians/midwifes and supervised by a coordinating midwife.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-10-28
• Study First Submitted QC: 2015-10-29
• Study First Posted: 2015-11-01
• Study Start: 2016-12-05
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-12
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1532

Inclusion Criteria

• patients over the age of majority,
• enrolled in one of the two maternity hospitals in the study before 12 weeks of amenorrhea (SA) and 6 days (j) of age,
• affiliated to the National Health Insurance Fund of the country within the regional level health insurance
• have an internet access

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Exclusion Criteria

• illiterate patients,
• non-French speakers,
• under the age of majority,
• refusing to participate,
• without internet access,
• followed by one of these maternity wards but delivering else where,
• whose pregnancy ended in a miscarriage early or late (before 21 weeks of amenorrhea (SA) and 6 days (J) over).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	control	-
PROSPERO group (intervention group)	PROSPERO	-

Primary Outcome Measures

Name	Time	Method
Rate of patients'pathway approved as compliant in the intervention group compared to the control group.	at the end of pregnancy	Compliant patient pathways are those for which all actions (medical visits, examinations, ...) recommended during pregnancy, according to the specific risk factors of each patient, will have been made.

Secondary Outcome Measures

Name	Time	Method
rate of severe maternal morbidity and mortality as defined by the EPIdémiologie de la MOrbidité Maternelle Sévère (EPINOMS) project	From 22 completed weeks (154 days) of gestation to seven completed days after birth
types of delivery	within one week from the date of delivery	rate of vaginal delivery, instrumental extraction delivery, Caesarean delivery
rate of perinatal morbidity-mortality as defined by the Organization, Practices Evaluation in perinatal Network	From 22 completed weeks (154 days) of gestation to seven completed days after birth
health care costs	one week from the date of delivery	duration of medical visits and hospitalization
patients' satisfaction : Qualitative evaluation by interview	within one week from the date of delivery	Qualitative evaluation of patients' satisfaction and adherence by interview and/or focus groups.
patients' satisfaction : Quantitative evaluation by the hospital anxiety and depression scale	within one week from the date of delivery	Quantitative evaluation of patients' satisfaction and anxiety by the hospital anxiety and depression scale and other validated's patient satisfaction forms
completeness of all hospital medical records	the end of pregnancy (the date of delivery)	completeness of hospital medical records compared to electronic patient-reported outcome (ePRO).

Trial Locations

Locations (2)

Hôpital Femme Mère Enfant; 🇫🇷 Bron, France

Hospices Civils de Lyon; 🇫🇷 Lyon, France